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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN 556-2:2015 - TC Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' Requirements for aseptically processed medical devices
immediate downloadReleased: 2020-02-24
BS EN 556-2:2015 - TC Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' Requirements for aseptically processed medical devices

BS EN 556-2:2015 - TC

Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' Requirements for aseptically processed medical devices

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Standard number:BS EN 556-2:2015 - TC
Released:2020-02-24
ISBN:978-0-539-08335-4
Status:Tracked Changes
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BS EN 556-2:2015 - TC


This standard BS EN 556-2:2015 - TC Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.